Status:
TERMINATED
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
Lead Sponsor:
Pfizer
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity wi...
Detailed Description
The trial was terminated prematurely on Oct 15, 2013 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.
Eligibility Criteria
Inclusion
- Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample.
- Active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to 10.
- Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.
Exclusion
- Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day 1.
- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections
- Subjects with evidence of past or active tuberculosis
- Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01470313
Start Date
November 1 2011
End Date
November 1 2013
Last Update
January 29 2014
Active Locations (19)
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1
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
2
Pfizer Investigational Site
Oxford, Alabama, United States, 36203
3
Pfizer Investigational Site
Los Angeles, California, United States, 90045
4
Pfizer Investigational Site
Orange Park, Florida, United States, 32073